Navigated T2 STRATOSPHERE Inserters and Navigated Templates
FDA 510(k) clearance K191039 · decided 2019-08-26
Clearance details
- K-number
- K191039
- Device name
- Navigated T2 STRATOSPHERE Inserters and Navigated Templates
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-19
- Decision date
- 2019-08-26
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Infuse TM Bone Graft/Medtronic lnterbody Fusion Device (P000058/S099) | Medtronic Sofamor Danek USA, Inc. | 2026-07-28 |
| Infuse Bone Graft (P000054/S078) | Medtronic Sofamor Danek USA, Inc. | 2026-07-28 |
| INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S098) | Medtronic Sofamor Danek USA, Inc. | 2026-03-19 |
| INFUSE® Bone Graft (P000054/S077) | Medtronic Sofamor Danek USA, Inc. | 2026-03-19 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S097) | Medtronic Sofamor Danek USA, Inc. | 2026-02-24 |
| INFUSE Bone Graft (P000054/S076) | Medtronic Sofamor Danek USA, Inc. | 2026-02-24 |
| Infuse Bone Graft (P000058/S096) | Medtronic Sofamor Danek USA, Inc. | 2026-02-13 |
| INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |